Press Releases

Latest Press Release

Gaithersburg, MD – The Environmental Protection Agency has updated a policy which will result in fewer products required to be tested in the eyes of rabbits. The policy is the outcome of a multi-year project between industry, the EPA and the non-profit testing laboratory, the Institute for In Vitro Sciences (IIVS). Coordinated by The Accord Group, the project successfully identified three non-animal tests which can be used to in place of the rabbit test to determine the eye irritation potential of commonly used household cleaning products.
The majority of cleaning products in the US do not undergo pre-market registration. However, those which carry anti-microbial claims are considered pesticides and animal testing is required by the EPA before they can be sold.
“This policy illustrates the constructive way that industry and the regulatory community can work together to replace the use of animals in testing,” comments Dr. Rodger Curren, current CEO of IIVS and lead scientist on the project. “It took a lot of commitment and resources from industry and the EPA to turn this concept into a reality.” It is expected that these tests will provide useful information on the eye irritation of other types of products and result in even less animal testing in years to come.

Previous Press Releases

GAITHERSBURG, MD - Determination of skin sensitization potential is a critical toxicological endpoint in the safety assessment of new chemicals. Although the Guinea Pig Maximization Test (GPMT) and in vivo Local Lymph Node assay (LLNA) have traditionally been used to assess skin sensitization, recent activity has focused on the development of novel non-animal assays for the endpoint. As a culmination of these efforts, the Organization for Economic Cooperation and Development (OECD) published the following test guidelines for non-animal skin sensitization testing on 5 February 2015: ARE-Nrf2 Luciferase Test Method (also referred to as the KeratinoSensTM Assay) (OECD TG 442D) and Direct Peptide Reactivity Assay (DPRA) (OECD TG 442C). The Institute for In Vitro Sciences (IIVS), a participating laboratory in the validation studies for the KeratinoSensTM assay, is pleased to offer each of these non-animal assays for detecting skin sensitizers.

The KeratinoSensTM assay is a cell-based reporter gene assay which identifies skin sensitizers by measuring the induction of luciferase under the control of the antioxidant response element (ARE) derived from the human AKR1C2 gene. In the proposed Adverse Outcome Pathway (AOP) leading to skin sensitization, this method addresses the second key event, gene expression in keratinocytes associated with the antioxidant/electrophile response element (ARE)-dependent pathway. The IIVS laboratory participated in the validation studies led by Givaudan to assess the KeratinoSensTM assay which demonstrated that the assay was transferable, reproducible, and predictive as compared to the historical animal data. Following extensive review of the data by EURL ECVAM, the assay was endorsed by ECVAM, and the OECD followed with a test guideline. Based on our experiences with the assay, IIVS has developed a GLP protocol for broader use, and since 2011 has offered the assay as a commercial service.

The DPRA is an in chemico assay that identifies dermal sensitizers based on their reactivity with synthetic peptides containing either lysine or cysteine. The assay models the first key event, protein reactivity, in the skin sensitization AOP. Through collaboration with the method developers at Procter & Gamble, IIVS scientists received training, successfully transferred the technology in-house, and are offering the assay as a commercial service. IIVS is currently exploring the use of the DPRA method in combination with the KeratinoSensTM assay to improve predictions.

Given the complex cascade of events leading to skin sensitization, it is generally thought that an integrated testing approach combining multiple assays and in silico predictive tools will be needed to fully replace the animal based methods. There is a significant effort underway to ascertain how the non-animal assays may be combined to both qualitatively and quantitatively assess skin sensitization most effectively. IIVS toxicologist Dr. Kimberly Norman served as a member of the OECD Expert Panel on skin sensitization, and IIVS offers both OECD approved methods for non-animal skin sensitization testing, as part of our GLP-compliant laboratory testing services. Please contact us for information on these skin sensitization assays and how they may be used as part of an integrated testing strategy within your existing testing program.

GAITHERSBURG, MD, BRUSSELS, BE - The European Partnership for Alternative Approaches to Animal Testing (EPAA) has partnered with US based Institute for In Vitro Sciences (IIVS) to produce a series of training videos on non-animal testing methods for the safety evaluation of products and ingredients. The first video in the series focuses on the Bovine Corneal Opacity and Permeability assay - a replacement for the Draize eye irritation test that utilizes live rabbits.

“Videos can be an effective and efficient means to provide training to an international audience. Filmed entirely in our laboratory using our highly proficient biologists, the 13 minute video provides an accurate demonstration of the Bovine Corneal Opacity and Permeability assay for eye irritation,” states Erin Hill, Vice President and Co-founder of IIVS. “We are grateful that EPAA has funded this project which will help scientists throughout the world to adopt replacements for animal testing.”

The series will focus on non-animal methods which have Test Guidelines developed by the international harmonizing body, the Organization for Economic Co-operation and Development (OECD).

The next video to be produced will highlight the 3T3 Phototoxicity Assay. Dr. Tzutzuy Ramirez, EPAA’s 2014 industry co-chair and Gwenole Cozigou, EPAA Commission co-chair commented, “One of EPAA’s primary goals is to pool knowledge and resources to facilitate the acceptance of alternative approaches to animal testing. Working with IIVS on this project is an a good example of combining resources to achieve a common goal at an international level.”

The first completed video, with English subtitles, is freely available on the EPAA website. Subtitled versions in Chinese and Portuguese will be available by the end of the year.

GAITHERSBURG, MARYLAND – The Institute for In Vitro Sciences (IIVS) last week signed a Memorandum of Understanding with the National Institute for Food and Drug Control (NIFDC), a subordinate agency of the China Food and Drug Administration (CFDA). The two organizations will work collaboratively on a number of projects focused on cosmetic safety testing designed to promote in vitro (non-animal) techniques in China.

In November 2013, IIVS held a week long training workshop at the NIFDC laboratory in Beijing to teach in vitro techniques for cosmetic safety testing to Chinese regulators including those from provincial agencies. Under the new memorandum, the NIFDC will coordinate with IIVS to hold an annual training workshop titled “Techniques for In Vitro Assays for Cosmetics Testing”. Additionally the NIFDC agrees to participate in validation projects of new models or techniques developed within China.

The MOU was signed by Dr. Wang Youchun, Deputy Director-General of NIFDC and Erin Hill, Co-founder and Vice President of IIVS. “The NIFDC has a great responsibility to introduce in vitro techniques to a large number of regulators within China” states Ms. Hill. “IIVS is honored to assist them in achieving this goal. Additionally our expertise in validation projects will be helpful as new in vitro methods are developed within China.”

Since 2012, the Institute for Food and Cosmetic Control (IFCC) within the NIFDC has been responsible for the testing of cosmetics for pre-market approval, post market surveillance, and investigations in response to consumer complaints. A new in vitro laboratory is currently under construction which will be used for, among other things, hands-on training. Dr. Wang Gangli, Director of the IFCC commented, “With our expanded laboratory space and support from IIVS experts, we will be able to organize workshops to train many more scientists within China on the use of in vitro methods for testing of cosmetics.”

Following the signing ceremony IIVS visited the laboratories of the NIFDC center responsible for the testing of drugs; the National Center for Safety Evaluation of Drugs (NCSED). The center Director, Dr. Wang Jufeng, and staff discussed potential collaborations and uses of in vitro methods in the evaluation of drugs within China.

About IIVS: IIVS is a non-profit laboratory based organization with a mission to advance the use and regulatory acceptance of in vitro testing methods. IIVS provides laboratory testing services to industry as well as training and educational programs. www.iivs.org

GAITHERSBURG, MD, December 16, The Institute for In Vitro Sciences (IIVS), with support from its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA), conducted a training course on September 23-27 for in vitro safety testing methods for scientists from China’s NIFDC (National Institutes for Food and Drug Control), a division of the China Food and Drug Administration.

The training was held at the Institute for Food and Cosmetic Control (IFCC) of the National Institutes for Food and Drug Control (NIFDC) in Beijing. The goal of the training was to familiarize NIFDC scientists with the biological relevance, critical techniques and data interpretation of in vitro (non-animal) methods for safety testing. Twenty-eight participants from 18 provincial Institutes for Food and Drug Control, Institutes for Medical Device Control and Institute for Food and Drug Safety Evaluation of NIFDC attended. Lectures and hands-on laboratory sessions focused on methods for eye irritation, skin irritation and sensitization.

Wang Youchun, Vice Director-General of NIFDC spoke at the opening ceremony and emphasized that it is “very necessary to expedite training and research of in vitro cosmetic safety evaluation methods and promote in vitro safety evaluation technology application and academic exchanges in Food and Drug Control systems in order to adapt to the international cosmetics testing technology development and to meet the requirements for actual inspection work.”

The CFDA is currently responsible for the registration and subsequent post market surveillance of cosmetic products. While previous regulations have relied on animal testing, the regulatory and scientific community within China is investigating how existing knowledge of ingredients and in vitro testing could be incorporated into their regulatory framework.

“In vitro methods can provide significant technical advantages over animal models. Our training courses highlight the key technical steps that are necessary to generate relevant and reliable data,” explains Erin Hill, IIVS co-founder and Vice President for Program Development. According to NIFDC participants “the training not only facilitated the application of in vitro test methods in the domestic cosmetic industry, but also laid a solid foundation for the further academic exchange, technical cooperation and personnel training between NIFDC and IIVS.”

GAITHERSBURG, Md., May 28, 2013 — The Institute for In Vitro Sciences Inc., (IIVS) a world renowned leader in the validation, training, and application of non-animal test methods, announces the formation of ICARAA: Industry Council for the Advancement of Regulatory Acceptance of Alternatives. ICARAA was formed in response to international regulations that still require animal testing to assess the safety of cosmetic and personal care products. “Many companies have been working for decades to eliminate animal testing,” states Dr. Rodger Curren , President of IIVS. “As a non-profit organization with a mission to expand the use and acceptance of in vitro methods, IIVS is well positioned to assist international regulatory agencies in the adoption of such technologies. With the combined support of the industry partners we are able to significantly expand and sharpen our efforts.”

ICARAA activities focus on educational programs that include lectures, laboratory demonstrations, hands-on training and data interpretation. Priority is given to those in vitro tests that have been widely used by the personal care and cosmetic industries and recognized by the OECD. Currently, ICARAA is also working with a major university and a biotechnology company to help increase the number of in vitro testing laboratories in China as well as assist with the development of the technology required to conduct in vitro testing. ICARAA’s overall goal is to facilitate movement away from animal testing by China’s regulatory agencies.

ICARAA is currently comprised of a number of companies including:

Avon Products

BASF SE

British American Tobacco Group Research & Development

Colgate-Palmolive Company

The Estee Lauder Companies, Inc.

Kimberly-Clark Corporation

Mary Kay Inc.

Unilever

About the Institute for In Vitro Sciences (IIVS)

Founded in 1997 as a non-profit organization, IIVS is recognized as a leading provider of in vitro testing and training services. Rigorous scientific programs coupled with educational and outreach initiates have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit [www.iivs.org].[http://www.iivs.org]

“Strong international cooperation is the future of alternatives to animal testing”

‐ Memorandum of Understanding with US‐based Institute for In Vitro Sciences signed

‐ Researcher from Germany‐based Helmholtz Centre for Environmental Research awarded with the 3Rs Science Award 2012

16th November 2012, Brussels Centre de Conferences Albert Borschette: Today, the European Partnership for Alternative Approaches to Animal Testing (EPAA) organized its 8th Annual Conference in Brussels. EPAA is a unique collaboration between five EU Commission services and seven industry sectors ‐ animal health, chemicals, cosmetics, crop protection, fragrances, pharmaceuticals, soaps & detergents. Finding future alternatives to animal testing and ensuring their use in regulatory contexts will require stronger and greater international cooperation, delegates at the Annual European Partnership for Alternative Approaches to Animal Testing (EPAA) conference in Brussels heard today. Speaking at the conference, DG Enterprise and Industry’s Deputy Director General, Antti Peltomäki – speaking on behalf of European Commission Vice President Antonio Tajani ‐ stressed that while Europe has pioneered efforts in the 3Rs of replacing, reducing and refining animal testing, further progress for the sustainable development of innovative products worldwide lies in strengthened international cooperation.

DG Enterprise and Industry’s Director and EPAA Commission Co‐Chair, Gwenole Cozigou, echoed these remarks, concluding that 2012 has been a turning point for the EPAA. While EPAA remains committed to and works on promoting alternative approaches in Europe, it has to be ready for the global stage, and will also work towards developing synergies with other regions. In her keynote presentation, Dr Julia Scheel, EPAA’s Industry Co‐Chair, highlighted the relevance of international cooperation from an industry perspective, as reflected in EPAA’s 2012 lead theme. She reported on a number of promising activities developed or launched during 2012, such as reducing animal
numbers in vaccines batch testing and advancing 3Rs in other dedicated areas of regulatory toxicology including carcinogenicity and skin sensitization.

Marking this commitment to international cooperation, the EPAA Co‐chairs signed a Memorandum of Understanding with the US based Institute for In Vitro Sciences (IIVS) President Rodger Curren. EPAA and IIVS have agreed to establish a strategic partnership dedicated to the international dissemination of alternative techniques for safety evaluation. EPAA will provide sponsorship of up to €100,000 over the next two years to IIVS to support training activities in key regions, including China and Brazil. R. Curren stated that “EPAA’s efforts to promote international cooperation on 3Rs will be greatly complemented by our joint activities and solid international network.”

The conference which attracted around 150 delegates, also heard from the US Food and Drug Administration, the Chinese State Food and Drug Administration, the OECD and European Chemicals Agency. Speakers highlighted both the potential benefits as well as the main challenges arising from implementing increased collaboration on the 3Rs. EPAA also honoured Dr Nils Klüver from the German‐based Helmholtz Centre for Environmental Research with the annual 3Rs Science Award for 2012, for his project “Systematic approach to investigate outliers of the fish embryo test to increase its predictive capacity and applicability domain for acute fish toxicity and beyond”. Dr Klüver will now further develop his method in collaboration with EPAA partners, thanks to a €100,000 grant.

About EPAA

The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a joint initiative from the European Commission, European trade associations from seven industry sectors and individual companies (see partners here). It was launched in November 2005 with the purpose to promote the development and implementation of new 3Rs methods (replace, reduce, refine) in the field of safety testing. For further information on the EPAA or its projects

About IIVS

The Institute for In Vitro Sciences, Inc. is a non‐profit research and testing laboratory dedicated to the advancement of in vitro (non‐animal) methods worldwide. Founded in 1997, IIVS has worked with industry, academic laboratories and government agencies to implement in vitro testing strategies that limit animal use while supplying key information for product safety and efficacy decisions.
For further information on IIVS and its programs

At an award ceremony being held in London today, two groups shared the £50,000 Lush Training Prize for making ‘outstanding contributions’ to training researchers in non-animal methods.

The winners were:

The Institute for In Vitro Sciences, USA – for their work on training researchers from Brazil to China

InterNICHE, co-ordinated from the UK – for their training work in former Soviet states, South America and Africa

The new annual Lush Training Prize, a joint project between the global handmade cosmetics company and Ethical Consumer magazine, is designed to bring forward the date when products and chemicals are no longer tested on animals.

The Training Prize provides a useful illustration of the extent of animal testing in emerging economies and the importance for campaigners of moving into these new regions.

Rob Harrison from the Lush Prize said:

“Lush Prize winners in 2012 have included scientists, campaigners, lobbyists, training specialists and young researchers from eight countries. All these people play a vital role in the global movement to replace animal testing with methods that are now widely accepted to be both more humane and effective.”

Every year, it is estimated that more than 100 million animals – including mice, rabbits and rats – are used in testing laboratories around the world.

Gaithersburg, MD, November 16, 2012: The Institute for In Vitro Sciences (IIVS), a non-profit laboratory, received the first annual Lush Training Prize during an award ceremony in London yesterday. The prize is a joint project between the global handmade cosmetics company and Ethical Consumer magazine. Designed to bring forward the date when products and chemicals are no longer tested on animals, the prize recognizes individuals or organizations who have excelled in establishing training programs to make scientists aware of the range of available non-animal testing methods.

“At IIVS we believe the change to non-animal testing methods will be hastened through education and training. Seeing, touching, using these methods firsthand and understanding the results will change perceptions and practices,” said Rodger Curren, President of IIVS, during the awards ceremony in London. “Our trainings change the fuzzy image of ‘alternatives’ into the reality of better science and the removal of animal pain and suffering.”

The Lush Training Prize is one of 5 categories the cosmetics company is recognizing. Others include the Science Prize, Young Researcher Prize, the Public Awareness Prize and the Lobbying Prize. Over 180 nominations were submitted and a panel of 10 independent judges picked the winners from a short-list compiled by the Lush Prize Team.

IIVS shares the award with InterNICHE, an international network focusing on animal use and alternatives within biological sciences, medical and veterinary medical education.

About IIVS

IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal testing methods. Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit www.iivs.org.

BASF SE, the world’s leading chemical company, has provided U.S. based Institute for In Vitro Sciences (IIVS) with equipment critical to replacing the use of animals for eye irritation testing of certain chemicals. IIVS will place the units at each of its newly developed training laboratories in Xi’an, Beijing, and Guangzhou, China.

With a long history in the development and use of non-animal methods, BASF engineered and produced the instrument, known as an opacitometer, to provide a reliable, state-of the art, and commercially available platform for the Bovine Corneal Opacity and Permeability (BCOP) assay. “We determined that development of this equipment was necessary to standardize the BCOP assay for our own internal use. Realizing that it could help scientists around the world implement this important non-animal method, we made it commercially available in 2010 at production cost,” says Dr. Susanne Kolle, Head of Applied Alternative Methods at BASF SE. “We are proud to support IIVS’ efforts to promote the use of non-animal methods in China by providing three opacitometer kits.”

IIVS, a non-profit, laboratory-based organization, has recently expanded its international outreach and training program. Dr. Rodger Curren, President of IIVS, comments on the importance of the donation. “The three BASF opacitometer kits allow our staff to rapidly train Chinese scientists and regulators using state-of-the art equipment. The BCOP assay provides a predictive and cost effective alternative to the use of live animals for eye irritation testing.”

BASF has been a contributor to IIVS since 2010 and the two organizations have collaborated on several projects including inter-laboratory validation studies of non-animal methods.

About BASF

BASF is the world’s leading chemical company. Our portfolio ranges from chemicals, plastics, performance products and crop protection products to oil and gas. We combine economic success, social responsibility and environmental protection. Through science and innovation we enable our customers in almost all industries to meet the current and future needs of society. Our products and system solutions contribute to conserving resources, ensuring healthy food and nutrition and helping to improve the quality of life. We have summed up this contribution in our corporate purpose: We create chemistry for a sustainable future. BASF posted sales of about €73.5 billion in 2011 and had more than 111,000 employees as of the end of the year. BASF shares are traded on the stock exchanges in Frankfurt (BAS), London (BFA) and Zurich (AN). Further information on BASF is available on the Internet at www.basf.com. To find out more about BASF’s activities on alternatives to animal testing please visit www.alternatives.basf.com.

About IIVS

IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal testing methods. Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information please visit www.iivs.org.